Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

Guideline

In the past, various Regulatory Authorities have identified shortcomings in the standards being utilized for the recognition of organizations that conduct medical device audits for regulatory purposes. These standards were considered to be too generic and focused on commercial entities for commercial purposes. However, many organizations that work in the regulated environment of medical devices must comply with these generic requirements for other purposes.